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Risk of hypertension with regorafenib in cancer patients: a systematic review and meta-analysis

  • Pharmacoepidemiology and Prescription
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Abstract

Background

Regorafenib is a novel multikinase inhibitor approved for use in metastatic colorectal cancer (mCRC) and locally advanced gastrointestinal stromal tumors (GISTs). Hypertension is one of the major adverse events of this agent, but to date the incidence and risk of hypertension with regorafenib have not been systematically investigated. We have conducted a systematic review and meta-analysis of published clinical trials to determine its overall incidence and risk.

Methods

PubMed, Web of Science and abstracts presented at the American Society of Clinical Oncology annual meetings were searched to identify relevant studies published up to September 9, 2013. Eligible studies were prospective phase II or III clinical trials using regorafenib in cancer patients with data on hypertension available. The incidence and relative risk (RR) of hypertension were calculated using a random-effects model.

Results

Data from a total of 1,069 patients (regorafenib n = 750; controls n = 319) from five clinical trials were included for analysis. The overall incidence of all-grade and high-grade hypertension were 44.4 % [95 % confidence interval (CI) 30.8–59.0 %) and 12.5 % (95 % CI 5.2–27.1 %), respectively. The use of regorafenib in cancer patients was associated with a significantly increased risk of all-grade (RR 3.76, 95 % CI 2.35–5.99) and high-grade (RR, 8.39, 95 % CI 3.10–22.71) hypertension. The risk might vary with tumor types (P = 0.000).

Conclusions

Patients with cancer receiving regorafenib have a significantly higher risk of developing hypertension. Close monitoring and appropriate management of this hypertension are strongly recommended.

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Acknowledgments

This project is supported by grants from National Natural Science Foundation of China (81272252), Natural Science Foundation of Jiangsu Province (BK2011656).

Conflict of interest

None.

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Authors and Affiliations

  1. Department of Medical Oncology, Jinling Hospital, Medical School of Nanjing University, 305 East Zhongshan Road, Nanjing, Jiangsu Province, 210002, People’s Republic of China

    Zexing Wang, Jing Xu, Guichun Huang & Xiaoxiang Guan

  2. Department of Medical Oncology, Jinling Hospital, School of Medicine, Southern Medical University, Guangzhou, 510282, China

    Weiwei Nie & Xiaoxiang Guan

  3. Department of General Surgery, Jiangsu Cancer Hospital–Nanjing Medical University, 42 Baiziting Road, Nanjing, 210009, Jiangsu Province, People’s Republic of China

    Jinhai Tang

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  1. Zexing Wang
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  2. Jing Xu
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  3. Weiwei Nie
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  4. Guichun Huang
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  5. Jinhai Tang
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Corresponding authors

Correspondence to Jinhai Tang or Xiaoxiang Guan.

Additional information

Zexing Wang and Jing Xu contributed equally to this work.

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Wang, Z., Xu, J., Nie, W. et al. Risk of hypertension with regorafenib in cancer patients: a systematic review and meta-analysis. Eur J Clin Pharmacol 70, 225–231 (2014). https://doi.org/10.1007/s00228-013-1598-1

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  • DOI: https://doi.org/10.1007/s00228-013-1598-1

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